In the context of literature monitoring for adverse reactions to medicinal products (EMA GVP Module VI), a reasonable number of Market Authorization Holders have no ready answer to justify why they use each search formula for each specific product when Audit or Inspection time comes: in fact the search formula, responsible for all the inbound traffic in the… Read More »

Question on a LinkedIn group: V model for Agile? Life Science industry is using traditional V model for CSV. Should this model be changed for Agile based development, testing and validation. I believe we should be able to use the user stories instead URS as the basis of V model. Please share your thought. Thanks PJ Singh, PMP… Read More »